Quality ManagementISO 9001

Course Content & Learning Outcome/ Objective:

• Introduce the purpose and benefits of a Quality Management System, evolution of the ISO 9001 series of standards, the continuing development process of these standards and key ISO 9001 related concepts and terminology

• The 7 Quality Management Principles, their application and potential benefits

• Explain the structure, purpose, content and interrelationship of ISO 9000, ISO 9001, ISO 9004 and ISO 19011 and the difference between auditable standards and guidance documents.

• Discuss and explain the requirements of the ISO 9001 on a clause-by clause basis, and its relationship with ISO 9004 and the 8 Quality

• Management Principles to enhance understanding

• Explain the value of documentation, the documentation flexibility and circumstances of exclusion of the ISO 9001 requirements and the Process-based Quality Management System Model.

• Describe the certification/registration and accreditation processes, types of audits (1st, 2nd and 3rd party) and the differences between legal compliance and conformance with ISO standards.

• How to develop and use key audit tools like Matrix of Requirements, Process approach Audit Checklist & Audit Plan, CAR to enable “value added” QMS audit

• How to plan and prepare, conduct, report and follow-up QMS audits based on the “Process Approach” & “PDCA” audit Trail. Discuss various Audits

• Methodology, Audit Psychology, Questioning Techniques, Roles and Responsibility to collect and analyze evidence, exercise objectivity and make decisions on the significance of findings made in accordance to relevant audit criteria.

• Local requirements, culture, practices or approaches to auditing and the application of ISO 9001, as appropriate for each country in which the course is being presented.

• Outline Exemplar Global Auditor Certification requirements